Effectiveness of nurse-home visiting in improving child and maternal outcomes prenatally to age two years: a randomised controlled trial (British Columbia Healthy Connections Project).

BACKGROUND: We investigated the effectiveness of Nurse-Family Partnership (NFP), a prenatal-to-age-two-years home-visiting programme, in British Columbia (BC), Canada. METHODS: For this randomised controlled trial, we recruited participants from 26 public health settings who were: <25 years, nulliparous, <28 weeks gestation and experiencing socioeconomic disadvantage. We randomly allocated participants (one-to-one; computer-generated) to intervention (NFP plus existing services) or comparison (existing services) groups. Prespecified outcomes were prenatal substance exposure (reported previously); child injuries (primary), language, cognition and mental health (problem behaviour) by age two years; and subsequent pregnancies by 24 months postpartum. Research interviewers were masked. We used intention-to-treat analyses. (ClinicalTrials.gov, NCT01672060.) RESULTS: From 2013 to 2016 we enrolled 739 participants (368 NFP, 371 comparison) who had 737 children. Counts for child injury healthcare encounters [rate per 1,000 person-years or RPY] were similar for NFP (223 [RPY 316.17]) and comparison (223 [RPY 305.43]; rate difference 10.74, 95% CI -46.96, 68.44; rate ratio 1.03, 95% CI 0.78, 1.38). Maternal-reported language scores (mean, M [SD]) were statistically significantly higher for NFP (313.46 [195.96]) than comparison (282.77 [188.15]; mean difference [MD] 31.33, 95% CI 0.96, 61.71). Maternal-reported problem-behaviour scores (M [SD]) were statistically significantly lower for NFP (52.18 [9.19]) than comparison (54.42 [9.02]; MD -2.19, 95% CI -3.62, -0.75). Subsequent pregnancy counts were similar (NFP 115 [RPY 230.69] and comparison 117 [RPY 227.29]; rate difference 3.40, 95% CI -55.54, 62.34; hazard ratio 1.01, 95% CI 0.79, 1.29). We observed no unanticipated adverse events. CONCLUSIONS: NFP did not reduce child injuries or subsequent maternal pregnancies but did improve maternal-reported child language and mental health (problem behaviour) at age two years. Follow-up of long-term outcomes is warranted given that further benefits may emerge across childhood and adolescence.

The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial.

BACKGROUND: This study aimed to test, in real-world clinical practice, the effectiveness of a Transitional Care Stroke Intervention (TCSI) compared to usual care on health outcomes, self-management, patient experience, and health and social service use costs in older adults (≥ 55 years) with stroke and multimorbidity (≥ 2 chronic conditions). METHODS: This pragmatic randomized controlled trial (RCT) included older adults discharged from hospital to community with stroke and multimorbidity using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional (IP) team, and included care coordination/system navigation support, phone/video visits, monthly IP team conferences, and an online resource to support system navigation. The primary outcome was risk of hospital readmission (all cause) after six-months. Secondary outcomes included physical and mental functioning, stroke self-management, patient experience, and health and social service use costs. The intention-to-treat principle was used to conduct the primary and secondary analyses. RESULTS: Ninety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). No significant between-group differences were seen for baseline to six-month risk of hospital readmission. Differences favouring the intervention group were seen in the following secondary outcomes: physical functioning (SF-12 PCS mean difference: 5.10; 95% CI: 1.58-8.62, p = 0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51-11.50, p = 0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p = 0.005). No between-group differences were found in total healthcare costs or other secondary outcomes. CONCLUSIONS: Although participation in the TCSI did not impact hospital readmissions, there were improvements in physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs. Challenges associated with the COVID-19 pandemic, including the shift from in-person to virtual delivery, and re-deployment of interventionists could have influenced the results. A larger pragmatic RCT is needed to determine intervention effectiveness in diverse geographic settings and ethno-cultural populations and examine intervention scalability. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04278794 . Registered May 2, 2020.

Informing decision makers about public preferences for different modalities of cancer treatment in the Rhône-Alps region in France.

BACKGROUND: Alternative options to hospital care like home care or local health centers (LHCs) are being advocated. However, no study has measured citizens' preferences (who will finance these services via taxation) for these options. OBJECTIVES: We measured (i) citizens' preferences for these services, that is, respondents stated where they would like to get the treatment; (ii) the strength of their preference. METHODS: A computerized survey composed of (i) a decision aid to inform respondents about the three options; (ii) three scenarios, from light-to-heavy care, that respondents should rank from the most to the least preferred option of care. (iii) a contingent valuation survey (CVS) to assess how much respondents were willing to pay for their preferred option (except for hospital care if chosen, because it is the default option and free). (iv) a socio-demographic questionnaire. RESULTS: Data were collected from a representative sample of citizens living in the Rhône-Alps Region (n = 800). The heavier the care was, the more respondents preferred hospital care. Willingness to pay for additional taxation per household/month varied from €13.9 for light care in LHC to €19.1 for heavy home care. The small number of protesting respondents and outliers, and the close correlation between preferences, income, and WTP supports the validity of the CVS. CONCLUSION: In France, for cancer, not all citizens would prefer to be treated at home rather than in a hospital. Only less than a quarter would prefer LHC. These results show the mismatch between public health policies and the citizens' preferences.

Patient participation in the clinical encounter and clinical practice guidelines: The case of patients' participation in a GRADEd world.

It is widely acknowledged that the patient's perspective should be considered when making decisions about how her care will be managed. Patient participation in the decision making process may play an important role in bringing to light and incorporating her perspective. The GRADE framework is touted as an evidence-based process for determining recommendations for clinical practice; i.e. determining how care ought to be managed. GRADE recommendations are categorized as "strong" or "weak" based on several factors, including the "values and preferences" of a "typical" patient. The strength of the recommendation also provides instruction to the clinician about when and how patients should participate in the clinical encounter, and thus whether an individual patient's values and preferences will be heard in her clinical encounter. That is, a "strong" recommendation encourages "paternalism" and a "weak" recommendation encourages shared decision making. We argue that adoption of the GRADE framework is problematic to patient participation and may result in care that is not respectful of the individual patient's values and preferences. We argue that the root of the problem is the conception of "values and preferences" in GRADE - the framework favours population thinking (e.g. "typical" patient "values and preferences"), despite the fact that "values and preferences" are individual in the sense that they are deeply personal. We also show that tying the strength of a recommendation to a model of decision making (paternalism or shared decision making) constrains patient participation and is not justified (theoretically and/or empirically) in the GRADE literature.

Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.

BACKGROUND: Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults and is associated with high comorbidity and burden. Studies show that lifestyle factors and self-management are associated with improved health outcomes, but many studies lack rigour or exclude older adults, particularly those with multimorbidity. More evidence is needed on the effectiveness of community-based self-management programs in older adults with T2DM and multimorbidity. The study purpose is to evaluate the effect of a community-based intervention versus usual care on physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with T2DM and 2 or more comorbidities. METHODS: Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada. Participants were randomly allocated to the intervention or control group in this pragmatic randomized controlled trial comparing the intervention to usual care. The intervention involved up to three in-home visits, a monthly group wellness program, monthly case conferencing, and care coordination. The primary outcome was physical functioning. Secondary outcomes included mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use. Intention-to-treat analysis was performed using ANCOVA modeling. RESULTS: Of 132 enrolled participants (70-Intervention, 62-Control), 42% were 75 years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM). No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: - 3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: - 1.12, 3.60; p-value: 0.30), or other secondary outcomes.. CONCLUSION: No significant group differences were seen for the primary outcome, physical functioning (PCS). Program implementation, baseline differences between study arms and chronic disease management services that are part of usual care may have contributed to the modest study results. Fruitful areas for future research include capturing clinical outcome measures and exploring the impact of varying the type and intensity of key intervention components such as exercise and diet. TRIAL REGISTRATION: NCT02158741 Date of registration: June 9, 2014.

Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial.

BACKGROUND: Older adults (> 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities. METHODS: Participants will be considered eligible if they are > 65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions. DISCUSSION: A nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population. TRIAL REGISTRATION: # NCT03157999 . Registration Date: April 4, 2017.

The British Columbia Healthy Connections Project: findings on socioeconomic disadvantage in early pregnancy.

BACKGROUND: Maternal exposure to socioeconomic disadvantage increases the risk of child injuries and subsequent child developmental and mental health problems - particularly for young mothers. To inform early intervention planning, this research therefore aimed to describe the health and social adversities experienced by a cohort of girls and young women in early pregnancy in British Columbia (BC), Canada. METHODS: Participants were recruited for the BC Healthy Connections Project (BCHCP), a randomized controlled trial examining the effectiveness of Nurse-Family Partnership, a home visitation program, in improving child and maternal outcomes. Baseline data were collected from 739 participants on trial entry. Participants were selected on the basis of preparing to parent for the first time and experiencing socioeconomic disadvantage. Analyses involved descriptive statistics and age-group comparisons. RESULTS: Most participants reported having low income (84%), having limited education (52%) and being single (91%) at trial entry. Beyond these eligibility criteria, other health and social adversities included: housing instability (52%); severe anxiety or depression (47%); other diagnosed mental disorders (22%); prenatal nicotine and cannabis use (27 and 21%); physical health problems (20%); child maltreatment when younger (56%); and intimate partner violence recently (50%). As well, few (29%) had received income assistance entitlements. More than two thirds (70%) were experiencing four or more forms of adversity. Age-group differences were observed for cognitive functioning, being single, low income, limited education, psychological distress and service use (p-value ≤0.05). CONCLUSIONS: This cohort was selected on the basis of socioeconomic disadvantage. Yet all participants were experiencing substantial added adversities - at higher rates than other Canadians. Furthermore, despite Canada's public programs, these pregnant girls and young women were not being adequately reached by social services. Our study adds new data to inform early intervention planning, suggesting that unacceptably high levels of socioeconomic disadvantage exist for some young British Columbians. Therefore greater health and social supports and services are warranted for these young mothers and their children. TRIAL REGISTRATION: Registered August 24, 2012 with ClinicalTrials.gov Identifier: NCT01672060 . Active not recruiting.

Insights on multimorbidity and associated health service use and costs from three population-based studies of older adults in Ontario with diabetes, dementia and stroke.

BACKGROUND: Most studies that examine comorbidity and its impact on health service utilization focus on a single index-condition and are published in disease-specific journals, which limit opportunities to identify patterns across conditions/disciplines. These comparisons are further complicated by the impact of using different study designs, multimorbidity definitions and data sources. The aim of this paper is to share insights on multimorbidity and associated health services use and costs by reflecting on the common patterns across 3 parallel studies in distinct disease cohorts (diabetes, dementia, and stroke) that used the same study design and were conducted in the same health jurisdiction over the same time period. METHODS: We present findings that lend to broader Insights regarding multimorbidity based on the relationship between comorbidity and health service use and costs seen across three distinct disease cohorts. These cohorts were originally created using multiple linked administrative databases to identify community-dwelling residents of Ontario, Canada with one of diabetes, dementia, or stroke in 2008 and each was followed for health service use and associated costs. RESULTS: We identified 376,434 indviduals wtih diabetes, 95,399 wtih dementia, and 29,671 with stroke. Four broad insights were identified from considering the similarity in comorbidity, utilization and cost patterns across the three cohorts: 1) the most prevalent comorbidity types were hypertension and arthritis, which accounted for over 75% of comorbidity in each cohort; 2) overall utilization increased consistently with the number of comorbidities, with the vast majority of services attributed to comorbidity rather than the index conditions; 3) the biggest driver of costs for those with lower levels of comorbidity was community-based care, e.g., home care, GP visits, but at higher levels of comorbidity the driver was acute care services; 4) service-specific comorbidity and age patterns were consistent across the three cohorts. CONCLUSIONS: Despite the differences in population demographics and prevalence of the three index conditions, there are common patterns with respect to comorbidity, utilization, and costs. These common patterns may illustrate underlying needs of people with multimorbidity that are often obscured in literature that is still single disease-focused.

Less-tight versus tight control of hypertension in pregnancy.

BACKGROUND: The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear. METHODS: We performed an open, international, multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure of 90 to 105 mm Hg (or 85 to 105 mm Hg if the woman was taking antihypertensive medications), and a live fetus. Women were randomly assigned to less-tight control (target diastolic blood pressure, 100 mm Hg) or tight control (target diastolic blood pressure, 85 mm Hg). The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days. The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge, whichever was later. RESULTS: Included in the analysis were 987 women; 74.6% had preexisting hypertension. The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35), as were the rates of serious maternal complications (3.7% and 2.0%, respectively; adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84), despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg (95% CI, 3.7 to 5.4). Severe hypertension (≥160/110 mm Hg) developed in 40.6% of the women in the less-tight-control group and 27.5% of the women in the tight-control group (P<0.001). CONCLUSIONS: We found no significant between-group differences in the risk of pregnancy loss, high-level neonatal care, or overall maternal complications, although less-tight control was associated with a significantly higher frequency of severe maternal hypertension. (Funded by the Canadian Institutes of Health Research; CHIPS Current Controlled Trials number, ISRCTN71416914; ClinicalTrials.gov number, NCT01192412.).

Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data.

BACKGROUND: WHO has targeted that medicines to prevent recurrent cardiovascular disease be available in 80% of communities and used by 50% of eligible individuals by 2025. We have previously reported that use of these medicines is very low, but now aim to assess how such low use relates to their lack of availability or poor affordability. METHODS: We analysed information about availability and costs of cardiovascular disease medicines (aspirin, ß blockers, angiotensin-converting enzyme inhibitors, and statins) in pharmacies gathered from 596 communities in 18 countries participating in the Prospective Urban Rural Epidemiology (PURE) study. Medicines were considered available if present at the pharmacy when surveyed, and affordable if their combined cost was less than 20% of household capacity-to-pay. We compared results from high-income, upper middle-income, lower middle-income, and low-income countries. Data from India were presented separately given its large, generic pharmaceutical industry. FINDINGS: Communities were recruited between Jan 1, 2003, and Dec 31, 2013. All four cardiovascular disease medicines were available in 61 (95%) of 64 urban and 27 (90%) of 30 rural communities in high-income countries, 53 (80%) of 66 urban and 43 (73%) of 59 rural communities in upper middle-income countries, 69 (62%) of 111 urban and 42 (37%) of 114 rural communities in lower middle-income countries, eight (25%) of 32 urban and one (3%) of 30 rural communities in low-income countries (excluding India), and 34 (89%) of 38 urban and 42 (81%) of 52 rural communities in India. The four cardiovascular disease medicines were potentially unaffordable for 0·14% of households in high-income countries (14 of 9934 households), 25% of upper middle-income countries (6299 of 24,776), 33% of lower middle-income countries (13,253 of 40,023), 60% of low-income countries (excluding India; 1976 of 3312), and 59% households in India (9939 of 16,874). In low-income and middle-income countries, patients with previous cardiovascular disease were less likely to use all four medicines if fewer than four were available (odds ratio [OR] 0·16, 95% CI 0·04-0·57). In communities in which all four medicines were available, patients were less likely to use medicines if the household potentially could not afford them (0·16, 0·04-0·55). INTERPRETATION: Secondary prevention medicines are unavailable and unaffordable for a large proportion of communities and households in upper middle-income, lower middle-income, and low-income countries, which have very low use of these medicines. Improvements to the availability and affordability of key medicines is likely to enhance their use and help towards achieving WHO's targets of 50% use of key medicines by 2025. FUNDING: Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries.

A randomized trial of planned cesarean or vaginal delivery for twin pregnancy.

BACKGROUND: Twin birth is associated with a higher risk of adverse perinatal outcomes than singleton birth. It is unclear whether planned cesarean section results in a lower risk of adverse outcomes than planned vaginal delivery in twin pregnancy. METHODS: We randomly assigned women between 32 weeks 0 days and 38 weeks 6 days of gestation with twin pregnancy and with the first twin in the cephalic presentation to planned cesarean section or planned vaginal delivery with cesarean only if indicated. Elective delivery was planned between 37 weeks 5 days and 38 weeks 6 days of gestation. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity, with the fetus or infant as the unit of analysis for the statistical comparison. RESULTS: A total of 1398 women (2795 fetuses) were randomly assigned to planned cesarean delivery and 1406 women (2812 fetuses) to planned vaginal delivery. The rate of cesarean delivery was 90.7% in the planned-cesarean-delivery group and 43.8% in the planned-vaginal-delivery group. Women in the planned-cesarean-delivery group delivered earlier than did those in the planned-vaginal-delivery group (mean number of days from randomization to delivery, 12.4 vs. 13.3; P=0.04). There was no significant difference in the composite primary outcome between the planned-cesarean-delivery group and the planned-vaginal-delivery group (2.2% and 1.9%, respectively; odds ratio with planned cesarean delivery, 1.16; 95% confidence interval, 0.77 to 1.74; P=0.49). CONCLUSIONS: In twin pregnancy between 32 weeks 0 days and 38 weeks 6 days of gestation, with the first twin in the cephalic presentation, planned cesarean delivery did not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00187369; Current Controlled Trials number, ISRCTN74420086.).

Twin Birth Study: 2-year neurodevelopmental follow-up of the randomized trial of planned cesarean or planned vaginal delivery for twin pregnancy.

BACKGROUND: The Twin Birth Study randomized women with uncomplicated pregnancies, between 32(0/7)-38(6/7) weeks' gestation where the first twin was in cephalic presentation, to a policy of either a planned cesarean or planned vaginal delivery. The primary analysis showed that planned cesarean delivery did not increase or decrease the risk of fetal/neonatal death or serious neonatal morbidity as compared with planned vaginal delivery. OBJECTIVE: This study presents the secondary outcome of death or neurodevelopmental delay at 2 years of age. STUDY DESIGN: A total of 4603 children from the initial cohort of 5565 fetuses/infants (83%) contributed to the outcome of death or neurodevelopmental delay. Surviving children were screened using the Ages and Stages Questionnaire with abnormal scores validated by a clinical neurodevelopmental assessment. The effect of planned cesarean vs planned vaginal delivery on death or neurodevelopmental delay was quantified using a logistic model to control for stratification variables and using generalized estimating equations to account for the nonindependence of twin births. RESULTS: Baseline maternal, pregnancy, and infant characteristics were similar. Mean age at assessment was 26 months. There was no significant difference in the outcome of death or neurodevelopmental delay: 5.99% in the planned cesarean vs 5.83% in the planned vaginal delivery group (odds ratio, 1.04; 95% confidence interval, 0.77-1.41; P = .79). CONCLUSION: A policy of planned cesarean delivery provides no benefit to children at 2 years of age compared with a policy of planned vaginal delivery in uncomplicated twin pregnancies between 32(0/7)-38(6/7)weeks' gestation where the first twin is in cephalic presentation.

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial.

INTRODUCTION: For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes. MATERIAL AND METHODS: This was a planned, secondary analysis of data from the 987 women in the CHIPS Trial. Logistic regression was used to examine the impact of 19 candidate predictors on the probability of adverse perinatal (pregnancy loss or high level neonatal care for >48 h, or birthweight <10th percentile) or maternal outcomes (severe hypertension, preeclampsia, or delivery at <34 or <37 weeks). A model containing all candidate predictors was used to start the stepwise regression process based on goodness of fit as measured by the Akaike information criterion. For face validity, these variables were forced into the model: treatment group ("less tight" or "tight" control), antihypertensive type at randomization, and blood pressure within 1 week before randomization. Continuous variables were represented continuously or dichotomized based on the smaller p-value in univariate analyses. An area-under-the-receiver-operating-curve (AUC ROC) of ≥0.70 was taken to reflect a potentially useful model. RESULTS: Point estimates for AUC ROC were <0.70 for all but severe hypertension (0.70, 95% CI 0.67-0.74) and delivery at <34 weeks (0.71, 95% CI 0.66-0.75). Therefore, no model warranted further assessment of performance. CONCLUSIONS: CHIPS data suggest that when women with chronic hypertension develop an elevated blood pressure in pregnancy, or formerly normotensive women develop new gestational hypertension, maternal and current pregnancy clinical characteristics cannot predict adverse outcomes in the index pregnancy.

Patterns of health service use in community living older adults with dementia and comorbid conditions: a population-based retrospective cohort study in Ontario, Canada.

BACKGROUND: Patients with dementia have increased healthcare utilization and often have comorbid chronic conditions. It is not clear if the increase in utilization is driven by dementia, the comorbidities or both. The objective of this study was to describe the number and types of comorbid conditions in a population-based cohort of older adults with dementia and how the level of comorbidity impacts dementia-related and non-dementia-related health service utilization. METHODS: This study is a retrospective cohort study using multiple linked administrative databases to examine health service utilization and costs of 100,630 community-living older adults living with pre-existing dementia in Ontario, Canada. Comorbid conditions and health service utilization were measured using administrative data (physician visits, emergency department visits, hospitalizations, and homecare contacts). RESULTS: Nearly all, 96.3 %, had at least one comorbid condition, while 18.4 % had five or more comorbid conditions. The most common comorbid conditions were hypertension (77.8 %), and arthritis (66.2 %). All types of utilization increased consistently with the number of comorbid conditions. The average number of dementia-related services tended to be similar across all levels of comorbidity while the average number of non-dementia related visits tended to increase with the level of comorbidity. CONCLUSIONS: Comorbidities in community-living older adults with dementia are common and account for a substantial proportion of health service use and costs in this population. Our results suggest that comprehensive programs that take a holistic view to identify the needs of patients in the context of other comorbidities are required for persons with dementia living in the community.

The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the Early External Cephalic Version 2 (EECV2) Trial.

OBJECTIVE: According to the Early External Cephalic Version (EECV2) Trial, planning external cephalic version (ECV) early in pregnancy results in fewer breech presentations at delivery compared with delayed external cephalic version. A Cochrane review conducted after the EECV2 Trial identified an increase in preterm birth associated with early ECV. We examined whether a policy of routine early ECV (i.e., before 37 weeks' gestation) is more or less costly than a policy of delayed ECV. METHODS: We undertook this analysis from the perspective of a third-party payer (Ministry of Health). We applied data, using resources reported in the EECV2 Trial, to the Canadian context using 10 hospital unit costs and 17 physician service/procedure unit costs. The data were derived from the provincial health insurance plan schedule of medical benefits in three Canadian provinces (Ontario, Alberta, and British Columbia). The difference in mean total costs between study groups was tested for each province separately. RESULTS: We found that planning early ECV results in higher costs than planning delayed ECV. The mean costs of all physician services/procedures and hospital units for planned ECV compared with delayed ECV were $7997.32 versus $7263.04 in Ontario (P < 0.001), $8162.82 versus $7410.55 in Alberta (P < 0.001), and $8178.92 versus $7417.04 in British Columbia (P < 0.001), respectively. CONCLUSION: From the perspective of overall cost, our analyses do not support a policy of routinely planning ECV before 37 weeks' gestation.

Thyroid cancer patient perceptions of radioactive iodine treatment choice: Follow-up from a decision-aid randomized trial.

BACKGROUND: Patient decision aids (P-DAs) inform medical decision making, but longer term effects are unknown. This article describes extended follow-up from a thyroid cancer treatment P-DA trial. METHODS: In this single-center, parallel-design randomized controlled trial conducted at a Canadian tertiary/quaternary care center, early-stage thyroid cancer patients from a P-DA trial were contacted 15 to 23 months after randomization/radioactive iodine (RAI) decision making to evaluate longer term outcomes. It was previously reported that the use of the computerized P-DA in thyroid cancer patients considering postsurgical RAI treatment significantly improved medical knowledge in comparison with usual care alone. The P-DA and control groups were compared for the following outcomes: feeling informed about the RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, and physician trust. In a subgroup of 20 participants, in-depth interviews were conducted for a qualitative analysis. RESULTS: Ninety-five percent (70 of 74) of the original population enrolled in follow-up at a mean of 17.1 months after randomization. P-DA users perceived themselves to be significantly more 1) informed about the treatment choice (P = .008), 2) aware of options (P = .009), 3) knowledgeable about treatment benefits (P = .020), and 4) knowledgeable about treatment risks/side effects (P = .001) in comparison with controls. There were no significant group differences in decision satisfaction (P = .142), decision regret (P = .199), cancer-related worry (P = .645), mood (P = .211), or physician trust (P = .764). In the qualitative analysis, the P-DA was perceived to have increased patient knowledge and confidence in decision making. CONCLUSIONS: The P-DA improved cancer survivors' actual and long-term perceived medical knowledge with no adverse effects. More research on the long-term outcomes of P-DA use is needed.

Empirical Testing of the External Validity of a Discrete Choice Experiment to Determine Preferred Treatment Option: The Case of Sleep Apnea.

There is an increasing use of the discrete choice experiment (DCE) method in health care to estimate preferences of individuals and the public for different services. Despite this increasing use, there are few studies that investigate the validity of the DCE in health. This study investigates the external validity of DCE by comparing the predicted treatment choices from the DCE to the actual treatment choices made by the same respondents using a decision board (DB) approach. The sample includes 140 patients who came for a sleep apnea routine visit in a hospital setting. Each respondent answered 10 DCE tasks and 1 DB task. The preferences were estimated with a generalized multinomial logit model and the predicted and actual treatment choices were compared both at the sample and individual levels. The results raise questions about the external validity of DCE in health. At the sample level, the comparison showed large but not significant differences between the two methods. This can be explained in part by the aggregation process that obscures variability in the individuals' preferences. At the individual level, the comparison showed that the two methods led to significantly different patterns of choices.

Oncologists' Perceptions of Recurrent Ovarian Cancer Patients' Preference for Participation in Treatment Decision Making and Strategies for When and How to Involve Patients in This Process.

OBJECTIVES: The treatment decision-making (TDM) process in the medical encounter in ovarian cancer (OC) is directed by oncologists. There is little information on oncologists' perceptions of this process. Our objectives were to explore oncologists' perceptions concerning (1) patients' preference for involvement in TDM, (2) factors that affect when to introduce this discussion, and (3) strategies used for engaging women in TDM. METHODS: We adopted a qualitative descriptive approach. Individual in-person interviews were used to collect data; themes were identified. RESULTS: Fifteen gynecologic and 5 medical oncologists from Ontario, Canada, participated. We found that oncologists made the assumption that women with recurrent OC were interested in being involved in TDM but rarely reported attempting to validate this assumption. The oncologists timed the initiation of the TDM discussion based on their degree of certainty of recurrent OC and their perception of the patient's readiness to be involved in TDM. Oncologists reported using strategies to engage women such as getting the women to take ownership of the decision, verbalize their priorities, lead the discussions, and giving the opportunity to gather information. CONCLUSIONS: Oncologists need to listen to each patient rather than make assumptions about the person based on her disease.

How oncologists communicate information to women with recurrent ovarian cancer in the context of treatment decision making in the medical encounter.

BACKGROUND: Women with recurrent ovarian cancer depend on their physicians to provide them with information about their diagnosis and available treatment options if they wish to participate in the process of choosing the treatment. There is no information on how oncologists give information to women during the physician-patient encounter at the time the disease recurs. OBJECTIVES: To explore from the oncologists' perspective (i) the extent to which oncologists provide their own patients who are experiencing their first recurrence of ovarian cancer with the same information about management options, and (ii) any explicit or implicit criteria they use to decide whether and how to tailor the information to individual patients. METHODS: We adopted a qualitative, exploratory descriptive approach to begin to understand oncologists' perspectives on how they gave information to patients within the context of their clinical practice. Individual interviews were used to identify themes related to the study objectives. RESULTS: Fifteen gynaecologic and five medical oncologists participated. Theme 1 describes the extent to which oncologists give information to their patients in the same way or in different ways. This section describes how the same oncologist may modify the depth of information transfer based on several factors. Theme 2 focuses on the factors that influence what information is given. For example, the amount and type of information given is based on the oncologist's on-going assessment of how the patient is assimilating the information shared during the medical encounter, the oncologists' perception of their relationship with the patient and the oncologist's assessment of what role they should take in decision making. Theme 3 involves the factors that influenced how information is given. For example, the information shared may vary based on the oncologist's perception of the patient's vitality, the patient's comprehension of the information, the patient's emotional well-being. In addition, the oncologist may make the information relevant for the patient by using analogies. Different types of information may be shared based on the oncologist's perception of patient- or family-initiated question. The information relay may be curtailed based on competing demands for the oncologist. DISCUSSION AND CONCLUSIONS: Oncologists provide women with information on their disease status, their treatment options and the side effects of treatment. The oncologists use perceptions to determine what information and how to provide information. The question this paper raises is whether the oncologist's perceptions reflect the individual patient's information and decision-making needs.

A randomized controlled trial of an intervention for infants' behavioral sleep problems.

BACKGROUND: Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep. METHODS: Two hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire. RESULTS: One hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9% of intervention and 97.9% of control infants had an average of 2 or more nightly wakes, a risk difference of -0.2% (95% CI: -1.32, 0.91). 4% of intervention and 14% of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of -10% (CI: 0.11, 0.84-16.8 to -2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: -3.7 to -0.4), fatigue (CI: -5.74 to -1.68), sleep quality (CI: -1.5 to -0.2), and sleep cognitions: doubts (CI: -2.0 to -0.6), feeding (CI: - 2.1 to - 0.7), anger (CI: - 1.8 to - 0.4) and setting limits (CI: -3.5 to -1.5). CONCLUSIONS: The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls. TRIAL REGISTRATION: ISRCTN42169337 , NCT00877162.